Feasibility of a Vocational Rehabilitation Intervention for Job Retention in Workers With MS-RiaLSM Intervention Project

Official title

Development and Assessment of a Vocational Rehabilitation Intervention for Job Retention in Workers With Multiple Sclerosis (RiaLSM Intervention Project)

Overview

Multiple sclerosis (MS) is an autoimmune demyelinating disease of the central nervous system with both inflammatory and degenerative characteristics that affects approximately 136,000 people in Italy. The highest incidence of disease onset occurs between the ages of 20 and 40, which corresponds to the most productive period of a person's life. For this reason, one of the main social consequences of MS is the reduction or abandonment of work activity, which often begins in the early stages of the disease. Vocational Rehabilitation (VR) interventions, as reported in the literature, are used to manage and reduce work-related difficulties. The goal of VR is to enable individuals who experience difficulties in performing work activities to access, find, and maintain employment. This approach is characterized by its multi-professional and multidimensional nature, involving different types of interventions carried out by various professionals in diverse settings. The overall aim of the project is to define a Vocational Rehabilitation (VR) protocol to reduce work-related challenges and promote job retention for workers with MS within the Italian healthcare and social context. The intervention will be organised into three different areas: rehabilitation, reasonable accommodation and education. Participants will receive any of the three interventions or a combination of these. The study will involve a multidisciplinary team of doctors (e.g. neurologist, physiatrist), psychologists, occupational therapists, physiotherapists, social workers, and labour law experts who will be involved according to the subject's specific needs.

Interventions

• Behavioral Vocational Rehabilitation intervention for pwMS
  The VR intervention will cover three areas of intervention: * Rehabilitation Area: this intervention has the goal of managing the work performance from a rehabilitative point of view. * Reasonable accommodation area: this intervention has the goal of assessing the needs of reasonable accommodations, such has workspace modification, change in organization of the activities, management of work time, etc.., and propose it to the employer. * Educational and Formative Area: this area is responsible

Primary outcome measures

• Interception [Time frame: Up to 6 months]
• Acceptance [Time frame: Up to 6 months]
• Adherence [Time frame: Up to 6 months]
• Lost to Follow-Up [Time frame: Up to 6 months]
• Canadian Occupational Performance Measure (COPM) [Time frame: Baseline, up to 6 months]
• Client Satisfaction Questionnaire (CSQ) [Time frame: Up to 6 months]
• Global Perceived Effect (GPE) scale [Time frame: Up to 6 months]
• Barthel Index (BI) [Time frame: Baseline, up to 6 months]
• Hospital Anxiety Depression scale (HADS) [Time frame: Baseline, up to 6 months]
• Modified Fatigue (MFIS-21) [Time frame: Baseline, up to 6 months]

Eligibility criteria

Inclusion criteria

• Confirmed MS diagnosis
• Age ≥18 years
• Currently employed at the beginning of the study entry
• Have worked at least one day in the last 12 months
• MSQ-Job >=15
• Written informed consent

Exclusion criteria

• Presence of other pathologies impacting on work productivity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Italy · 2 centers

• IRCCS Fondazione Santa Lucia — Rome
• Servizio di Riabilitazione AISM Liguria, Italian Multiple Sclerosis Society — Genoa

Publications

• Vitturi BK, Rahmani A, Dini G, Montecucco A, Debarbieri N, Bandiera P, Ponzio M, Battaglia MA, Brichetto G, Inglese M, Persechino B, Durando P. Work Barriers and Job Adjustments of People with Multiple Sclerosis: A Systematic Review. J Occup Rehabil. 2023 Sep;33(3):450-462. doi: 10.1007/s10926-022-10084-1. Epub 2022 Nov 18. PMID 36399281
• Ponzio M, Pignattelli E, Verri A, Grange E, Persechino B, Vitturi BK, Bandiera P, Manacorda T, Inglese M, Durando P, Battaglia MA. Job Retention by People With Disabilities: A Qualitative Study of the Perspectives of People With Multiple Sclerosis. Med Lav. 2024 Jun 21;115(3):e2024018. doi: 10.23749/mdl.v115i3.15947. PMID 38922837
• Ponzio M, Podda J, Pignattelli E, Verri A, Persechino B, Vitturi BK, Bandiera P, Manacorda T, Inglese M, Durando P, Battaglia MA. Work Difficulties in People with Multiple Sclerosis. J Occup Rehabil. 2024 Sep;34(3):606-617. doi: 10.1007/s10926-023-10149-9. Epub 2023 Nov 3. PMID 37921967
• Sweetland J, Riazi A, Cano SJ, Playford ED. Vocational rehabilitation services for people with multiple sclerosis: what patients want from clinicians and employers. Mult Scler. 2007 Nov;13(9):1183-9. doi: 10.1177/1352458507078414. Epub 2007 Jul 10. PMID 17623726
• Escorpizo R, Reneman MF, Ekholm J, Fritz J, Krupa T, Marnetoft SU, Maroun CE, Guzman JR, Suzuki Y, Stucki G, Chan CC. A conceptual definition of vocational rehabilitation based on the ICF: building a shared global model. J Occup Rehabil. 2011 Jun;21(2):126-33. doi: 10.1007/s10926-011-9292-6. PMID 21328061

Identifiers

NCT: NCT06805318 · CET Liguria:329/2024-DBid13998 · Grant BRic 2022, ID 31

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗